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Posted 23 October 2018 | By Ana Mulero 

TGA Proposes Regulation on IVD Companion Diagnostics


Australia’s Therapeutic Goods Administration (TGA) issued a consultation paper on Tuesday to propose a new framework for the regulation of companion in vitro diagnostic (IVD) devices.

The framework proposes 10 different modifications, subject to ministerial approval, to the current regulation on the assays, otherwise known as IVD companion diagnostics (CDx).

TGA argues the modifications are needed to address existing “concerns with the current regulatory model, particularly in relation to the classification of and premarket assessment of IVD CDx.” These include difficulties aligning assessments and corresponding products, Australian Register of Therapeutic Goods identification and user fees.

The proposals set forth in the consultation are largely based on the IVD CDx regulations in other jurisdictions—mainly in the US and Europe–in accordance with the government’s policy on aligning requirements and aiming to provide greater quality assurance and clarity to industry.

TGA’s move comes in response to the momentum of precision medicine, with growing interest in emerging technologies for targeted therapies. It also coincides with the ongoing efforts among agencies worldwide for regulatory harmonization.

According to TGA, the US Food and Drug Administration (FDA) has IVD CDx regulatory pathways that “are now well established” whereas the EU has yet to publish “the overarching regulations pertaining to companion diagnostics” that will come with the new IVD regulation. The differences between FDA’s regulatory approach and the one for EU IVDs are detailed in the consultation.

Key proposals relate to the newly introduced definition of an IVD CDx and the meaning of “essential for the safe and effective use” of the device type in the context of its definition as there is currently no set definition for this term in the Australian IVD regulations. It also seeks to require that the instructions for use of IVD CDx “shall stipulate the corresponding medicine or biological therapeutic good for which it is an IVD companion diagnostic.”

On the meaning of the term “essential for the safe and effective use,” TGA proposed to follow FDA’s model in order to “facilitate amendments and updates to the definition as necessary to address unintended interpretations of the regulations or future developments in this area.” The Australian regulatory agency also proposed that the term “be limited to diagnostic tests that are required in the labeling of the medicine/biological to ensure its safe and effective use.”


Other proposals cover classifying all CDx as Class 3 IVDs, requiring compulsory audits, unique product identifiers in applications and application audit fees, the transition of all existing entries to the new framework, a timeline for the transition, whether to include lab developed tests within the scope and concurrent reviews of corresponding products.

The consultation period on the new framework will last until close of business on 4 December, according to TGA. 


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